Dr Ben Goldacre
By email only to [FOI #24031 email]
FOI 09 473
1 February 2010
Dear Dr Goldacre
I am writing further to my letter of 30 December 2009 about your Freedom of
Information Act (FOIA) request of 30 November 2009 about statins.
You asked about delays in updating statin product information referred to in the
February 2008 Drug Safety Update (DSU) and specifically for:
1. all documents and correspondence relating to this delay;
2. the discussions between the MHRA, the EMEA, and the company
about the addition of this new side effects information to the side
effects listed on the label, and
3. the name of the company concerned.
Under section1(3) of the FOIA a public authority need not comply with a request
unless any further information reasonably required to locate the information is
supplied. If a request is too broad or general in nature (for example, seeking
information on a topic over many years), public authorities have a duty to provide
advice and assistance to the applicant in order to focus the request. A public
authority need not comply with a request where the cost of dealing with it would
exceed the appropriate limit, £600 for central government.
In relation to questions 1 and 2, to search for and provide all the documents and
correspondence we hold dating back to 2008 would exceed the amount of
information we can provide under the FOIA. I have included at Annex 1 a
chronology of events based on the limited information that the MHRA holds as this
may help you focus your request. When a requestor asks for documents held
over a large period I ask them to narrow their request down to a 3 month period
so that I can conduct a more focussed search.
In answer to question 3, following correspondence with their respective Reference
Member States (RMS) (see below), consultation was held with the Marketing
Authorisation Holders (MAHs) listed overleaf.
MAH Product
RMS
AstraZeneca Crestor The
(rosuvastatin)
Netherlands
(NL)
Bristol Myers Squibb
Lipostat (pravastatin) UK
Merck, Sharp & Dohme
Zocor (simvastatin)
UK
Novartis Lescol/Lescol
XL
France
(fluvastatin)
Pfizer Lipitor
(Atorvastatin)
Germany
Merck, Sharp & Dohme
Lovastatin
Spain
A number of MAHs sought clarification from their respective RMS. The MHRA
does not hold copies of all correspondence between each MAH and their RMS.
Following clarification from the MHRA, the last MAH to reach agreement on the
proposed wording was AstraZeneca in respect of Crestor. As the Netherlands is
the RMS for Crestor a significant amount of dialogue on this issue was between
the Dutch Medicines Evaluation Board (MEB) and AstraZeneca. MHRA does not
hold all correspondence or dialogue between AstraZeneca and the MEB or
between any other MAHs and their respective RMS so this is not included at
Annex A. You may also wish to contact the MEB and EMEA to see what
information they hold.
AstraZeneca are aware that this information has been
released into the public domain but do not know who has requested this
information.
Background
By way of background on the products that your request refers to, there are 6
brand leading statins, all licensed through the Mutual Recognition (MR)
procedure, although only 5 are marketed in the UK. This means the MAH applies
for a licence in one Member State, which then applies throughout the EU. The
Member State the MAH applies to is known as the RMS. The RMS leads on the
regulation of that medicine including updates to product information. I should add
that in law, the product information is copyright of the MAH and the legal duty is
on them to update it. If they do not agree to update information because they do
not believe that it is warranted based on the safety data that they have
accumulated, they have the opportunity to set out reasons why or request further
data from regulators to support the regulator’s proposal. Ultimately though,
regulators can compel MAHs to update information but this is only done if
voluntary agreement cannot be reached.
Voluntary agreement was reached in
this case.
Following the publication of the UK's statin review in February 2008, the
conclusions of the review were considered by the European Pharmacovigilance
Working Party (PhVWP) of the Committee for Medicinal Products for Human Use
(CHMP) and were then released as a UK Public Assessment Report (PAR) in
November 2009.
Since the new information applied to the entire class of medicines, it was
important to ensure a co-ordinated, Europe-wide approach to the changes.
Anything less than an across the board approach could have had patient safety
implications resulting from inappropriate switching between statins. The Member
States responsible for the 6 brand leading statins were asked to liaise with the
relevant companies about the introduction of the new product information.
Implementation of the changes across the statin class was dependent on all
MAHs agreeing to the wording for the proposed new product information.
However, not all MAHs immediately agreed with the need for implementation as
based on their safety data, they did not believe common wording across the class
was appropriate. They considered that the product information for each product
should be based solely on safety data for that product, and not others of the same
class and some sought further clarification on this from their RMS.
As the UK had already made health professionals aware at a very early stage in
the consultation that the statin review was ongoing through the DSU article, we
considered that health professionals would communicate this to patients as
appropriate.
If I do not hear from you within 20 days I will assume you do not wish to proceed
with your request. If you wish to discuss any aspect of your request please
contact me.
Yours sincerely
Stephen Fawbert
Mr Stephen Fawbert
Freedom of Information Coordinator
Vigilance and Risk Management of Medicines Division
Tel: 020 7084 2788
Enc
The information supplied in response to your request is the copyright of MHRA and/or a third party or
parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use
any information provided without prior agreement from the copyright holder. For full details on our
copyright policy please visit:
http://www.mhra.gov.uk/home/Idcplg?IdcService=SS_GET_PAGE&nodeId=412or e-mail the MHRA
Information Centre
Annex A
Chronology since February 2008 based on information held by the MHRA
DATE
4 February 2008
MHRA Drug Safety update published
June 2008
UK implementation plan agreed by
PhVWP
July 2008
Letters sent to innovator MA Holders
by relevant RMS about inclusion of
core wording across the class
9 July 2008
NL receive response from AZ stating
that based on their safety data core
wording was not warranted at this
time. AZ requested data via the RMS
from the PhVWP to justify the
inclusion of core wording.
19 February 2009
NL receive further response from AZ
stating that based on their safety data
and the limited information provided,
core wording was not warranted at
this time.
6 May 2009
AZ response to NL preliminary
assessment report of PSUR 11
stating why core wording was not
warranted at this time and clarification
to justify the inclusion of core wording
sought.
8 October 2009
MHRA Telecon with AZ
16 October 2009
MHRA/MEB Meeting with AZ
20 October 2009
UK update to PhVWP
26 October 2009
Letters sent to UK MA Holders
3 November 2009
MHRA Drug Safety update published
3 November 2009
Statins UKPAR published
Document Outline
